brivaracetam / Generic mfg. - LARVOL DELTA

Continuous-Flow Synthesis of Antiepileptic Drugs: Process Intensification, Sustainability Metrics, and Scalable Manufacturing. (PubMed, ACS Omega) - "The review will examine examples of recent advances in continuous-flow processing of major molecules, including pregabalin, levetiracetam, lacosamide, and brivaracetam. In addition, the review will discuss the obstacles preventing a complete transition to an automated, environmentally friendly, and continuous-flow process for producing AEDs."

Journal • Review

Cognitive Side Effects of Antiseizure Medications in Adults with Epilepsy: An Update with a Focus on New Therapeutic Agents. (PubMed, CNS Drugs) - "Overall, newer-generation ASMs, including rufinamide, lacosamide, brivaracetam, cannabidiol, fenfluramine, and ganaxolone, demonstrate generally favourable cognitive profiles when used at recommended doses, particularly in monotherapy or rational polytherapy. Eslicarbazepine and cenobamate may be associated with mild, dose-dependent cognitive effects, occurring only at the upper end of the recommended dose range. In contrast, old ASMs and certain second-generation agents, notably topiramate and zonisamide, remain consistently associated with higher cognitive risks...Cognitive dysfunction in epilepsy is multifactorial, reflecting the interaction between disease-related neurobiological mechanisms and treatment effects. Optimal management requires balancing seizure control with cognitive preservation through individualised drug selection, cautious titration, and minimisation of polytherapy to achieve the best functional and quality-of-life outcomes."

Adverse events • Journal • Review • CNS Disorders • Cognitive Disorders • Developmental Disorders • Epilepsy • Mental Retardation

Brivaracetam Bioequivalence Assessment (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: Zodiac Produtos Farmaceuticos S.A.

New P1 trial

Clinical Response and Tolerability of Brivaracetam in Pediatric Epilepsy: A Systematic Review and Meta-analysis. (PubMed, J Child Neurol) - "This study reports that BRV is safe and effective in a pediatric population. These findings warrant the necessity for further studies in BRV effectiveness, with specificity toward different classifications of epilepsy, ideal dosages for beneficence, and larger trials."

Journal • Review • CNS Disorders • Epilepsy • Pediatrics

Narrative Review: Efficacy, Safety, and Tolerability of Newer Third-Generation Antiseizure Medications for Focal Epilepsy: A New Benchmark in Treatment Outcomes? (PubMed, Neurol Ther) - "All third-generation ASMs were effective adjunctive therapies. Cenobamate was associated with higher responder and seizure freedom rates and higher long-term retention rates. Brivaracetam and lacosamide had favorable tolerability profiles. The notable seizure freedom rates with cenobamate suggest a potential new benchmark in focal seizure treatment. Comparator trials are needed to confirm possible efficacy and tolerability differences among third-generation ASMs."

Journal • Review • CNS Disorders • Eosinophilia • Epilepsy • Fatigue • Pain • Psychiatry

Increased Libido Following Brivaracetam Initiation: A Case Report of Temporal Lobe Epilepsy. (PubMed, Neuropsychopharmacol Rep) - "Previous reports have described increased libido with levetiracetam, which shares the same mechanism of action with BRV. Genetic factors, such as reduced striatal dopamine receptor density associated with DRD2/ANKK1 polymorphisms may contribute to psychiatric side effects. In this case, BRV-associated modulation of neurotransmission may have interacted with a vulnerable dopaminergic system, as indicated by the need for BXP. Preexisting bilateral hippocampal atrophy may also have provided a structural substrate resembling a pharmacologically induced incomplete Klüver-Bucy syndrome. Clinicians should be aware that patients may hesitate to report such symptoms and should actively monitor for changes in libido after initiating BRV."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Epilepsy • Psychiatry • Sexual Disorders • DRD2

Cognitive and Neurochemical Effects of Brivaracetam Co-Administered with Ethanol: A Preclinical Study. (PubMed, Int J Mol Sci) - "Brivaracetam may counteract ethanol-induced manganese brain concentration, but increases iron, magnesium, and copper concentrations. Hence, brivaracetam use induces various effects on the central nervous system."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • CAT

Brivaracetam in Combination with Midazolam and Ketamine Reduces Soman-Induced Seizure and Neurodegeneration in Rats. (PubMed, Neurol Int) - "Although further research is needed to determine optimal drug combinations, these preclinical findings provided further evidence that simultaneous polytherapy with ASMs improves OPNA-induced seizure outcomes."

Journal • Preclinical • CNS Disorders • Epilepsy • Inflammation • Pediatrics

The effect of antiseizure medications on the exposure to combined oral contraceptives: A systematic review and network meta-analysis. (PubMed, Epileptic Disord) - "Current recommendations may underestimate ASM effects on exposure to COC components, especially those in newer COCs. Greater caution is recommended with low-dose topiramate. For individuals treated with weak COC inducers without additional contraceptive means, COCs containing levonorgestrel or norethindrone might be preferable given their lower vulnerability to induction."

Journal • Retrospective data • CNS Disorders • Epilepsy

Pharmacokinetics, Safety, and Dosing of Antiseizure Medications in Patients with Renal or Hepatic Impairment. (PubMed, Clin Pharmacokinet) - "Ten newer antiseizure medications (ASMs) approved since 2000 and selected for this review (cenobamate, brivaracetam, eslicarbazepine acetate, lacosamide, perampanel, fenfluramine, ganaxolone, cannabidiol, stiripentol, and rufinamide) have broadened treatment options for drug-resistant epilepsy. Regulatory discrepancies between FDA and EMA labeling were identified for all ten agents, notably divergent hepatic dose caps for perampanel and cenobamate, conflicting renal recommendations for fenfluramine, and discordant guidance for eslicarbazepine acetate in severe renal impairment. These agents exhibit no uniform class effect in organ impairment; prescribing must be governed by agent-specific disposition profiles, organ-function severity, and free-drug monitoring for highly protein-bound agents like perampanel and ganaxolone."

Journal • PK/PD data • Review • CNS Disorders • Epilepsy • Hepatology • Nephrology • Renal Disease

Exploring the impact of controlled substance restrictions on epilepsy care in the United States: A neurologist survey. (PubMed, Epilepsy Behav) - "Respondents reported high rates of medication access issues related to controlled substance restrictions and low rates of ASM misuse. Controlled substance restrictions create practical barriers to reliably obtaining scheduled ASM prescriptions that can result in increased risk of morbidity and mortality. Controlled substance restrictions warrant reevaluation for PWE given the specific risk-benefit tradeoffs for this life-threatening neurologic condition."

Journal • CNS Disorders • Epilepsy

Characterization, healthcare resource utilization, and costs of health equity clusters of Medicaid-insured patients with epilepsy: An exploratory machine learning approach. (PubMed, Epilepsy Res) - "Results suggest a relationship between formulary restrictions and economic burden, seemingly independent of age, sex, geographic region, and treatment utilization."

HEOR • Journal • Reimbursement • US reimbursement • CNS Disorders • Epilepsy

EXPAND: A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy (clinicaltrials.gov) - P3 | N=153 | Completed | Sponsor: UCB Biopharma SRL | Active, not recruiting ➔ Completed

Monotherapy • Trial completion • Absence Seizure Disorder • CNS Disorders • Epilepsy

Eco-friendly MIP-based electrochemical sensor for selective detection of brivaracetam in plasma. (PubMed, Anal Bioanal Chem) - "The method was effectively utilized to quantify BRV in its pharmaceutical dosage form and in spiked human plasma. An evaluation of its greenness through AGREE, GAPI, and MoGAPI indicated the environmentally friendly aspects of the developed method."

Journal

Antiseizure medication dosing and monitoring in the intensive care unit: a practical narrative review. (PubMed, Intensive Care Med) - "The use of ASMs in the ICU require a distinct approach from outpatient settings. Severity of illness, organ dysfunction and replacement devices, and frequent drug-drug interactions warrant tailored agent selection, dosing, and monitoring."

Journal • Review • CNS Disorders • Critical care • Epilepsy

Anti-seizure medication in Germany over 25 years: trends in prices and prescription patterns from national data from 2000 to 2024. (PubMed, Epilepsy Behav) - "The observed prescription shifts align well with the recommendations of German clinical practice guidelines, which advocate preferential use of lamotrigine and levetiracetam and lacosamide as first-line agents in focal epilepsies, whilst discouraging the use of enzyme-inducing ASMs due to their unfavourable pharmacokinetic interaction profiles and long-term tolerability concerns. The sustained stability of total ASM expenditure indicates that the German pharmaceutical regulatory framework seems to have contributed effectively to contain ASM expenditures whilst maintaining access to therapeutic innovations."

Journal • CNS Disorders • Epilepsy

Trends in antiseizure medication use among women of childbearing age with epilepsy. (PubMed, J Neurol Sci) - "These findings indicate a shift in ASM treatment patterns among WOCBA over the past 13 years. Despite recommendations to restrict the use of third-generation ASMs in this population due to insufficient data regarding teratogenicity, the mean daily doses of lacosamide and especially brivaracetam were relatively high. These results highlight the need for further research to explore possible dose-related teratogenicity for individual third-generation ASMs."

Journal • CNS Disorders • Epilepsy

A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy (clinicaltrials.gov) - P3 | N=70 | Active, not recruiting | Sponsor: UCB Biopharma SRL | Recruiting ➔ Active, not recruiting | N=120 ➔ 70 | Trial completion date: Mar 2030 ➔ Nov 2029 | Trial primary completion date: Mar 2030 ➔ Nov 2029

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Absence Seizure Disorder • CNS Disorders • Epilepsy

Brivaracetam as viable monotherapy option for focal and generalized epilepsy. (PubMed, Epilepsy Behav) - "In this retrospective real-world cohort, BRV monotherapy was associated with favorable short-term seizure outcomes and good tolerability. Particularly favorable outcomes were observed after conversion from LEV. Although long-term retention decreased over time, a substantial proportion of patients continued to benefit from BRV monotherapy over a two-year period, despite BRV being the initial monotherapy in only 25% of the cohort. Overall, these findings suggest that BRV may represent an effective and well-tolerated monotherapy option for selected patients and provide support for further prospective studies evaluating its role in both focal and generalized epilepsies."

Journal • Monotherapy • CNS Disorders • Epilepsy • Psychiatry

Compound POMGNT1 Variants Associated with Muscle-Eye-Brain Disease: Necessity of Comprehensive Genetic Testing (EAN 2026) - "Electroencephalography confirmed refractory epileptic encephalopathy, which ultimately responded to a four-drug antiepileptic regimen (valproate sodium, brivaracetam, zonisamide, lacosamide). Combined genetic and histopathological results were consistent with Muscle-Eye-Brain disease (MEB), a dystroglycanopathy within the CMD spectrum. Over one-third of MEB patients have epilepsy, approximately 20% of which suffer from refractory seizures. This case illustrates how compound heterozygosity with residual POMGNT1 activity permits prolonged survival, while predisposing to severe adult-onset neurological complications, necessitating extensive genetic testing to resolve complex neuromuscular phenotypes."

Cataract • CNS Disorders • Developmental Disorders • Epilepsy • Genetic Disorders • Muscular Dystrophy • Myositis • Ocular Inflammation • Ophthalmology • Ventriculomegaly • LAMB2

Effectiveness and safety of brivaracetam in patients with focal epilepsy: A systematic review and meta-analysis. (PubMed, Epilepsy Res) - "Adjunctive BRV achieves a pooled responder rate of 44.0%, with results stable on sensitivity analysis. Longer duration of epilepsy may be associated with reduced effectiveness. BRV exhibits an acceptable safety profile, supporting its use as an adjunctive option for focal epilepsy."

Journal • Retrospective data • CNS Disorders • Epilepsy • Fatigue • Pain

Delirium in critically ill patients treated with levetiracetam or brivaracetam: a comparative study. (PubMed, Seizure) - "In this cohort, LEV was independently associated with a higher risk of delirium compared to BRV, and inpatient LEV-to-BRV switch was associated with delirium resolution. Delirium was associated with prolonged ICU and hospital admissions. Prospective multicenter studies with standardized monitoring are needed."

Journal • Anesthesia • CNS Disorders • Critical care • Epilepsy • Psychiatry

Determination of Residual Nitrilase in Brivaracetam Using Characteristic Peptides by Liquid Chromatography-Mass Spectrometry. (PubMed, Rapid Commun Mass Spectrom) - "In this study, a sensitive and reliable LC-MS/MS method was developed for the determination of residual nitrilase in brivaracetam. The proposed method may serve as a general analytical strategy for quality control of nitrilase-related pharmaceutical products."

Journal

Lacosamide versus brivaracetam as adjunctive therapy for drug-resistant focal epilepsy: A placebo-anchored indirect comparison and network meta-analysis. (PubMed, Epilepsy Res) - "In adults with drug-resistant focal epilepsy, placebo-anchored indirect evidence did not show a clear difference in short-term efficacy between adjunctive LCM and BRV. Estimates for selected tolerability outcomes were imprecise and based on low-certainty, fully indirect evidence. These findings do not establish a definitive comparative advantage of either treatment, and direct comparative studies are needed."

Journal • Retrospective data • Review • CNS Disorders • Epilepsy

Sodium channel blockers are associated with reduced dementia risk in late-onset unexplained epilepsy. (PubMed, medRxiv) - "Using data from over 75 million adults aged 55 years or older, we found that sodium channel blockers were associated with a 27% lower hazard of incident all-cause dementia (hazard ratio = 0.73, 95% confidence interval 0.61- 0.88) and 34% lower hazard of Alzheimer's disease (hazard ratio = 0.66, 0.49 -0.88), compared with levetiracetam/brivaracetam. While the class effect was protective, individual agents such as phenytoin, carbamazepine, and lamotrigine showed divergent safety and efficacy profiles. We replicated these findings in both a Down syndrome cohort and the external National Alzheimer's Coordinating Center dataset. Our results suggest that targeting neuronal excitability with sodium channel blockers is associated with lower risk of dementia, prioritizing the repurposing of these agents for dementia prevention trials."

Journal • Alzheimer's Disease • CNS Disorders • Dementia • Developmental Disorders • Epilepsy • Genetic Disorders